NCT00513084

Brief Summary

The primary objectives of this randomized clinical trial are a) to implement and test the impact of a 1-year lifestyle obesity treatment program based on Self-Determination Theory on 3-year change in physical activity and motivation for exercise/physical activity, body weight and fat, and selected eating variables, b) to identify behavioral and psychosocial theory-based moderators or mediators of primary outcomes, especially physical activity and body weight.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
259

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 8, 2007

Status Verified

July 1, 2007

First QC Date

August 7, 2007

Last Update Submit

August 7, 2007

Conditions

Obesity

Keywords

Behavioral,Self-Determination Theory,Motivational Interviewing,Exercise, Physical Activity,Motivation,Moderators,Mediators,Predictors,Weight

Outcome Measures

Primary Outcomes (1)

  • Primary outcomes are physical activity/exercise and body weight/ composition. Physical activity is assessed by accelerometry and standardized interview/questionnaire methods. Body composition is assessed by DXA

    baseline, 4, 12, 16, 24 and 36 months

Secondary Outcomes (1)

  • Dietary Intake, psychosocial SDT-based mediators

    baseline, 4, 12,16, 24 and 36 months

Study Arms (2)

SDT Intervention

EXPERIMENTAL

This arm will follow main experimental intervention, as described elsewhere

Behavioral: SDT and Motivational Interviewing in Obesity Treatment

Comparison Group

NO INTERVENTION

Comparison Group receiving standard care health promotion intervention

Interventions

SDT and Motivational Interviewing in Obesity TreatmentBEHAVIORAL

Thirty group sessions, designed to follow SDT, covering PA, eating/nutrition, body image, and other cognitive-behavioral contents. Central to the intervention are improving autonomy, intrinsic motivation, and self-regulation of behavior change. Accepting ambivalence for change, rolling with resistance, and developing discrepancy were used throughout the program, with an emphasis on promoting intrinsic, self-regulated motivation for exercise and weight control.

Also known as: GI: Intervention Group
SDT Intervention

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female (25-50 years old)
  • pre-menopausal
  • BMI between 25 and 40 kg/m2
  • willing to attend weekly meetings (during 1 year)
  • willing to not participate in other formal or informal weight loss program during the first year of the study (intervention group only).

You may not qualify if:

  • major/chronic illness
  • taking (or having taken in the previous year) medication known to interfere with body weight regulation, including anti-depressive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Human Movement, Technical University of Lisbon

Lisbon, Estrada Da Costa, 1495-688 Cruz-Quebrada, Portugal

Location

Related Publications (7)

  • Minderico CS, Silva AM, Fields DA, Branco TL, Martins SS, Teixeira PJ, Sardinha LB. Changes in thoracic gas volume with air-displacement plethysmography after a weight loss program in overweight and obese women. Eur J Clin Nutr. 2008 Mar;62(3):444-50. doi: 10.1038/sj.ejcn.1602709. Epub 2007 Mar 28.

    PMID: 17392701RESULT

  • Teixeira PJ, Going SB, Houtkooper LB, Cussler EC, Metcalfe LL, Blew RM, Sardinha LB, Lohman TG. Exercise motivation, eating, and body image variables as predictors of weight control. Med Sci Sports Exerc. 2006 Jan;38(1):179-88. doi: 10.1249/01.mss.0000180906.10445.8d.

    PMID: 16394972RESULT

  • Jorge R, Santos I, Tomas R, Silva MN, Carraca EV, Teixeira VH, Teixeira PJ. Behavioural and psychological pretreatment predictors of short- and long-term weight loss among women with overweight and obesity. Eat Weight Disord. 2020 Oct;25(5):1377-1385. doi: 10.1007/s40519-019-00775-9. Epub 2019 Sep 13.

    PMID: 31520301DERIVED

  • Carraca EV, Markland D, Silva MN, Coutinho SR, Vieira PN, Minderico CS, Sardinha LB, Teixeira PJ. Physical activity predicts changes in body image during obesity treatment in women. Med Sci Sports Exerc. 2012 Aug;44(8):1604-12. doi: 10.1249/MSS.0b013e31824d922a.

    PMID: 22330022DERIVED

  • Silva MN, Markland D, Carraca EV, Vieira PN, Coutinho SR, Minderico CS, Matos MG, Sardinha LB, Teixeira PJ. Exercise autonomous motivation predicts 3-yr weight loss in women. Med Sci Sports Exerc. 2011 Apr;43(4):728-37. doi: 10.1249/MSS.0b013e3181f3818f.

    PMID: 20689448DERIVED

  • Teixeira PJ, Silva MN, Coutinho SR, Palmeira AL, Mata J, Vieira PN, Carraca EV, Santos TC, Sardinha LB. Mediators of weight loss and weight loss maintenance in middle-aged women. Obesity (Silver Spring). 2010 Apr;18(4):725-35. doi: 10.1038/oby.2009.281. Epub 2009 Aug 20.

    PMID: 19696752DERIVED

  • Silva MN, Markland D, Minderico CS, Vieira PN, Castro MM, Coutinho SR, Santos TC, Matos MG, Sardinha LB, Teixeira PJ. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description. BMC Public Health. 2008 Jul 9;8:234. doi: 10.1186/1471-2458-8-234.

    PMID: 18613959DERIVED

MeSH Terms

Conditions

ObesityBehaviorMotor ActivityBody Weight

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Pedro J Teixeira, PhD

    Faculty of Human Movement, Technical University of Lisbon

    PRINCIPAL INVESTIGATOR

  • Luis B Sardinha, PhD

    Faculty of Human Movement, Technical University of Lisbon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Study Start

July 1, 2004

Study Completion

July 1, 2009

Last Updated

August 8, 2007

Record last verified: 2007-07

Locations

PT(1)